Regulatory Affairs Specialist

R&D Partners; Nova Iguaçu; Presencial; USD 99.000 - 123.000; Tempo integral

Resumo da oferta

An established industry player is looking for a Regulatory Affairs Specialist II to join their dynamic team. In this role, you will be responsible for compiling and maintaining regulatory documentation, coordinating submissions, and analyzing product complaints. Your expertise in US, EU, and Canada medical device regulations will be crucial in ensuring compliance and effective communication with regulatory agencies. With a comprehensive benefits package and a commitment to employee development, this opportunity promises to enhance your career in a supportive and innovative environment. Join a company that values your contributions and offers a pathway to professional growth.

Serviços

Medical insurance PPO, HMO & HSA

401k plan

Employee Assistance Program

Long-term disability

Weekly payroll

Online timecard approval

Qualificações

• 3-5 years of experience in regulatory affairs or related field.
• Strong knowledge of medical device regulations in key markets.

Responsabilidades

• Compile and maintain regulatory documentation databases.
• Coordinate the preparation of regulatory documents and submissions.
• Communicate with regulatory agencies on compliance strategies.

Conhecimentos

Regulatory Documentation Management

Regulatory Compliance Analysis

Employee Training Development

Knowledge of Medical Device Regulations (US, EU, Canada)

Formação académica

Bachelor's Degree in a related field

Ferramentas

PLM WindChill

Veeva RIM

Descrição da oferta de emprego

R&D Partners is seeking to hire a Regulatory Affairs Specialist II in Lake Forest, CA.

Your main responsibilities as a Regulatory Affairs Specialist II:

1. Compile and maintain regulatory documentation databases or systems.
2. Coordinate efforts associated with the preparation of regulatory documents or submissions.
3. Analyze product complaints and make recommendations regarding their reportability.
4. Develop or conduct employee regulatory training.
5. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.

What we are looking for in a Regulatory Affairs Specialist II:

1. 3-5 years of work experience
2. Knowledge of US, EU, and Canada Medical Device Regulations
3. Familiarity with PLM WindChill and Veeva RIM platforms (not a mandatory requirement)

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

1. Medical insurance PPO, HMO & HSA
2. 401k plan
3. Employee Assistance Program
4. Long-term disability
5. Weekly payroll
6. Online timecard approval

Salary: $99,611 - $122,283 (Dependent on Experience)

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.